Manage and support GMP QA consulting activities for RegDev, Inc. clients including QA oversight of manufacturing, validation, and testing operations at third party contractor operations.Manage and support GMP Inspection Readiness activities for RegDev clients. Responsible for implementing and managing cGMP Quality Systems at RegDev, Inc.

Responsible to lead the GMP Quality Compliance function at MEI Pharma, Inc. Serve senior management by acting as a strategic and tactical Quality/Compliance professional in directing the GMP Quality/Compliance function related to contract organizations and internal processes encompassing Good Manufacturing Practices (GMPs) and Good Distribution Practices (GDPs). Direct the vendor management program and other related activities including inspection readiness, inspection management, internal audits, external audits, and due diligence.Ensure oversight of compliance with FDA, EMA, and PMDA regulations and ICH guidelines applicable to GMPs and GDPs, industry best practices and internal policies and procedures. Conduct regulatory intelligence surveillance of industry trends and changing regulations and provide ownership and oversight of continuous improvement of GMP compliance processes. Partner with the Manufacturing, Supply Chain, Pharmaceutical Sciences and Technical Operations function groups within MEI Pharma, Inc. to provide strategic GDP and GMP compliance oversight for all MEI Pharma, Inc. programs and internal operations.

Directed the Central Quality Auditing & Due Diligence group of international global GxP auditors to audit (including for cause audits) all Global Alvogen suppliers, third party manufacturers (CMOs / CDMOs), service providers having a GxP impact as well as overseeing the conduct of internal audits of all Alvogen manufacturing sites, operational units and functional support groups with GxP impact (including GCP & Pharmacovigilance).Directed the Central Quality Auditing group to conduct GxP audits at internal entities and global external suppliers in line with Alvogen regional policies and procedures/guidelines, as well as regulatory requirements including but not limited to FDA, EMA, PIC/S & ICH GxP regulations/guidelines.

Reported to the Senior Director US-Quality. Directed Alvogen’s U.S. Third Party Quality (TPQ) Group. Six reports (two direct and four indirect), covering TPQ Operations (Commercial & Development), and supporting also corporate Alvogen’s U.S. Third-Party Quality Management Systems (QMS).Directed Quality and Compliance activities for drug products and active pharmaceutical ingredients (APIs) that were contract manufactured, tested, and supplied to Alvogen U.S. by 40+ global contract manufacturing organizations (CMOs / API Suppliers), with a $600M+ Annual Sales Value.Therapeutic product categories of U.S. marketed drug products included SODs (Tablets / Capsules), Topicals (Gels / Ointments), Semi-solids (Oral Suspensions), Transdermal Patches and Sublingual Film products. Previous therapeutic categories (in addition to the above) included Sterile Solutions (Otic & Ophthalmic) and Sterile Injectables (July 2016 through the end of 2018).Provided guidance and supervision to a team of Quality Managers and Senior Quality Managers who worked directly with Contract Manufacturing Organizations (CMOs, CDMOs)) and Alvogen business partners which manufactured and/or supplied commercially approved & development drug products for Alvogen U.S. Directed Alvogen U.S. Third-Party Quality review and approval of all CMO generated batch documentation, including but not limited to process validation protocols and reports, analytical test method validation protocols and reports, methods, specifications, labeling documents, master and executed batch manufacturing and packaging records, change controls, deviations / investigations and corrective and preventive actions.Ensured Quality Agreements were maintained with all suppliers, as required, including contract manufacturers, contract packagers, contract testing laboratories and API suppliers.Supported and/or conducted GMP audits of established and/or potential CMOs, CDMOs and external business partners.

Directed and executed Allergan's global GxP audit program covering both external supplier audit program and global internal audit program. Communicate external supplier and internal audit program initiatives and results. 4,000+ external supplier base (raw materials and contracted services) / 40+ global manufacturing sites / 15+ global research and development (R&D) centres.

Managed newly created Global Strategic Compliance Group within Allergan's Global Quality/Compliance Unit. Established and led ‘Global Supplier Task Force’ cross functional team to address problematic suppliers. Developed risk based strategies to manage problematic supplier cases.

July 2010 - November 2012: Direct responsibility to support the (cGMP) Compliance function for Actavis Pharmaceuticals at three of its global pharmaceutical production sites which were located at Alathur/Chennai in India, at Dupnitza in Bulgaria and at Edison New Jersey in the U.S. Also responsible to support the (cGMP) Compliance function for Actavis Pharmaceuticals throughout all of Latin America. Fluent in Spanish as a second language.Also - April 2009 to June 2010 - Manager, Global Compliance, Totowa NJ Site.

With seven direct reports, I managed the Compliance & Quality Assurance functions for Alpharma's Human Pharmaceuticals Division - supporting its Research & Development, Clinical Development and Commercial / Finished Product functions. Responsible for the creation, management, direction and administration of the Compliance and Quality functions for Alpharma’s (Branded) Human Pharmaceuticals Division. Majority of my responsibilities at the Piscataway NJ site were specifically chartered through the U.S. Code of Federal Regulations (CFR) to ensure compliance with FDA and DEA Regulations, as well as with all company policies, compliance guidelines, standards and objectives.

Global Compliance function: Conducted international and domestic site audits to support Alpharma's global pharmaceutical business. Hosted multiple FDA General GMP and Pre-Approval Inspections at two manufacturing sites (Elizabeth NJ & Baltimore MD).

Managed the cGMP Compliance function (R&D and post-marketing) for the Alpharma Elizabeth NJ manufacturing facility - 600+ employees covering the manufacture of 70+ generic oral solid dose pharmaceutical products.

Conducted internal and external (domestic and international) cGMP audits to support the Alpharma / Purepac Pharmaceutical Co. Elizabeth, NJ pharmaceutical manufacturing site. Supported the Manager of Site Compliance by: o Reviewing change controls, manufacturing and laboratory deviation / non-conformance investigations and Annual Product Review (APR) reports, and o Providing monthly cGMP initiation training for all new employees.